- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager, CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager, CMC Development and Dossiers is responsible for ... the coordination and authoring of high-quality Chemistry, Manufacturing, and Controls ( CMC ) documentation. Working closely with the respective SMEs, they support the… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) ... internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA CMC Lead, Vaccines **Location** : Morristown, NJ, Swiftwater, PA **About the Job** Are you ready to shape the future of medicine? The race is on ... was possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or… more
- Organon & Co. (Jersey City, NJ)
- …responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule and/or biological products in ... Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications...are not limited to: **Responsibilities** + Serve as the CMC Product Lead or support the CMC … more
- Organon & Co. (Jersey City, NJ)
- …for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of ... development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. + Serve as the… more
- Sanofi Group (Morristown, NJ)
- …solution architect to join our team. Mostly dedicated to Digital In Silico Research & CMC Operations domain, you will be a key strategic leader and will work closely ... leaders to establish the Digital In Silico Research & CMC technology strategy, in alignment with Sanofi's Digital global...of all solutions for Digital In Silico Research & CMC operations. Ensure alignment with architecture strategy and adhere… more
- Merck (Rahway, NJ)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... analysis and provides recommendation to governance for endorsement. + Represent CMC and effectively communicates across the governance bodies, stakeholders and… more
- Deloitte (Morristown, NJ)
- …experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML, ... Veeva Vault RIM, Lorenz docuBridge, MasterControl, or similar); and + Involvement with CMC modules (Module 3 of CTD/eCTD) for global submissions, as well as… more
- RWJBarnabas Health (Toms River, NJ)
- …Status:Per Diem Shift:Day Facility:Rutgers University Medical Grp Department:RWJMS Neurosurgery CMC Pay Range:$57.69 - $91.34 per hour Location: Toms River, ... Nurse Practitioner Location: Rutgers University Medical Grp Department Name: RWJMS Neurosurgery CMC Req #: 0000207607 Status: Hourly Shift: Day Pay Range: $57.69 -… more
- WuXi AppTec (Cranbury, NJ)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more